MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 SUMMIT POR TAPER SZ9 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157011165
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Necrosis (1971); Pain (1994); Tissue Damage (2104); Injury (2348); Osteolysis (2377); Not Applicable (3189)
Date of Event	07/18/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Complaint description: new etq record created in order to update etq (legacy system) complaint number wpc (b)(4).Reason for original complaint â¿.Litigation alleges that the patient suffered injury and pain.Update 12/19/2013 - sales rep reported revision surgery.Patient's femoral head was revised to address osteolysis.The cup remained in situ.There is no new additional information that would affect the investigation.The complaint was updated on: (b)(6) 2014.Update rec'd 09/26/2014- litigation papers received.Litigation alleges discomfort.There is no new additional information that would affect the investigation.The complaint was updated on: (b)(6) 2014.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  product complaint # (b)(4).Investigation summary: the asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa- 001226.Ongoing post market surveillance is conducted per our procedures for this product.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SUMMIT POR TAPER SZ9 HI OFF
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7479651
• Report Number: 1818910-2018-58751
• Device Sequence Number: 16191418
• Product Code: LPH
• UDI-Device Identifier: 10603295060109
• UDI-Public: 10603295060109
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K001991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 157011165
• Device Lot Number: BL3CB1000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 12/06/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 08/08/2018; 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR